A Study of RNA Tumor Vaccine in Patients With Advanced Solid Tumors

NCT05202561 | Unknown Phase 1

• 1 other identifier: LWY21084CBY
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, clinical pharmacology study to evaluate the safety of RNA tumor vaccine injection alone/in combination with PD-1 inhibitor in the treatment of advanced solid tumors with KRAS mutation. The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, pharmacokinetics and of RNA tumor vaccine.

Conditions

Advanced Solid Tumor

Keywords

KRAS mutation; RNA tumor vaccine; injection; PD-1; immunotherapy; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Graded according to the NCI CTCAE version 5.0.

  Up to 6 months

Secondary Outcomes (2)

• To evaluate the antitumor activity

  Up to 2 years

• The changes of the immunoreactivity during treatment.

  Up to 28 Days

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: RNA tumor vaccine Administration: intramuscular injection Dose: 600 ng/ time Dosing cycle: Day 1, day 4, day 7, and day 14.

Biological: RNA tumor vaccine

Arm B

EXPERIMENTAL

Drug: RNA tumor vaccine+Navuliumab Administration: intravenous injection Dose: 3 mg/kg Timing of administration: Administration was initiated 14 days after the first intramuscular injection of the RNA tumor vaccine. Duration of administration: once every 2 weeks.

Biological: RNA tumor vaccine+Navuliumab

Interventions

RNA tumor vaccine BIOLOGICAL

Subjects will receive single dose of RNA tumor vaccine injection on day 1, day 4, day 7, and day 14, each dose of 600 ng.

Arm A

RNA tumor vaccine+Navuliumab BIOLOGICAL

RNA tumor vaccine+Navuliumab Subjects will receive maintenance therapy with a PD-1 inhibitor in addition to monotherapy with the RNA tumor vaccine injection. Subjects received a single dose of RNA vaccine injection on day 1, day 4, day 7, and day 14, with each dose of 600 ng. Inhibitors, accept the Navuliumab on day 14, the recommended dose is 3 mg/kg, intravenous injection every 2 weeks.

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is at least 18 years old with no gender limitation;
• Patients with advanced malignant solid tumors confirmed by histopathology or cytology and failed to receive standard treatment or without standard treatment;
• Identification of at least one KRAS mutation: G12C, G12D or G12V;
• The subtype was identified as HLA-A11:01 or C08:02;
• Have at least one measurable lesion according to RECIST V1.1;
• ECOG PS score was 0-2 in the Eastern Oncology Group;
• Full organ and bone marrow function, as defined below:
• Sign written informed consent and be able to comply with the visits and related procedures specified in the program;
• Eligible fertile patients (male and female) must agree to use a reliable contraceptive method (hormonal or barrier methods or abstinence) during the study period;

You may not qualify if:

• A history of severe allergy to biological products;
• Those in pregnancy or lactation;
• The expected survival time is less than 3 months;
• Those who have undergone major surgery within 4 weeks prior to signing the informed consent, or who plan to undergo major surgery during the study period;
• Received chemotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor drugs within 2 weeks before the first administration;
• Participating in other clinical studies;
• Patients with central nervous system metastasis or a history of central nervous system metastasis;
• Adverse effects of previous antitumor therapy have not recovered to NCI CTCAE V5.0 rating ≤1 (except hair loss);
• Serious cardiovascular and cerebrovascular diseases, hypertension that is still poorly controlled after standard treatment (systolic blood pressure \> 150mmHg, diastolic blood pressure \> 90mmHg);
• Patients with active ulcers and gastrointestinal bleeding;
• Patients with uncontrollable pleural effusion, abdominal effusion and pericardial effusion;
• Active infection requiring treatment;
• HIV, HCV, syphilis, CMV, EBV infected patients; Patients with active HBV replication;
• A history of interstitial lung disease;
• The patient has an autoimmune disease or is in an immunosuppressed state; Current systemic steroid use (except recent or current inhaled steroid use);

Sponsors & Collaborators

• The First Affiliated Hospital of Bengbu Medical University: lead

Study Sites (1)

First Affiliated Hospital Bengbu Medical College

Bengbu, Anhui, 233030, China

RECRUITING

Central Study Contacts

zhou huan, MD

CONTACT

13665527160; zhouhuanbest@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: January 21, 2022
• Study Start: March 10, 2022
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2024
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)